Senior Quality Manager - Injection Molding - Leominster, MA

Lead Quality Strategy

Lead quality strategy for a growing, high-impact medical device site. Drive continuous improvement within an injection molding environment.

About Our Client

Our client is a well-established advanced manufacturing organization known for delivering highly engineered products in an injection molding regulated industry. They are committed to operational excellence, innovation, and fostering a collaborative culture where quality is embedded throughout the business.

Job Description

Lead and continuously improve the Quality Management System (QMS), ensuring compliance with regulatory and customer requirements. Develop and execute quality strategies, objectives, and improvement initiatives aligned with business goals. Manage audits, CAPA programs, complaint investigations, non-conformance activities, and regulatory inspections. Partner with cross-functional teams to drive quality performance, risk management, and operational excellence. Analyze quality metrics and trends to identify improvement opportunities and support data-driven decision-making. Oversee quality assurance activities including inspections, validation, metrology, calibration, and manufacturing process controls. Lead, mentor, and develop the quality team while fostering a culture of quality, compliance, safety, and continuous improvement.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

Bachelor's degree in Engineering, Quality, Applied Science, Business, or a related technical field. 5+ years of quality management experience within medical device manufacturing. Strong experience managing Quality Management Systems and leading quality audits. Working knowledge of medical device quality and regulatory standards, including ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR 820. Experience with APQP, control plans, validation activities, metrology, MSA, capability studies, and quality improvement methodologies. Proven success leading CAPA programs, complaint investigations, risk assessments, and root cause analysis initiatives. Demonstrated leadership experience with responsibility for coaching, developing, and managing teams. Strong analytical, organizational, and project management skills. Excellent written and verbal communication skills with the ability to engage customers, auditors, and executive leadership. Professional certifications such as ASQ CMQ/OE, CQE, or CQA are highly preferred. Ability to manage multiple priorities in a fast-paced manufacturing environment.

What's on Offer

Strategic leadership position with significant organizational visibility. Opportunity to shape and evolve quality systems and processes. Collaborative environment that values innovation and continuous improvement. Exposure to customer-facing and regulatory leadership responsibilities. Career growth potential within a respected and expanding organization. Comprehensive benefits and PTO package.

Job summary: Sector: Engineering & Manufacturing. Sub Sector: Quality, Technical. Industry: Industrial / Manufacturing. Where: Leominster. Contract Type: Permanent.